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Generated: October 19, 2018

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QSYMIA Drug Profile

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When do Qsymia patents expire, and what generic alternatives are available?

Qsymia is a drug marketed by Vivus and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.

Drug patent expirations by year for QSYMIA
Generic Entry Opportunity Date for QSYMIA
Generic Entry Date for QSYMIA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for QSYMIA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-004 Jul 17, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-004 Jul 17, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-001 Jul 17, 2012 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-002 Jul 17, 2012 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for QSYMIA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-004 Jul 17, 2012 ➤ Sign Up ➤ Sign Up
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-001 Jul 17, 2012 ➤ Sign Up ➤ Sign Up
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 ➤ Sign Up ➤ Sign Up
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-002 Jul 17, 2012 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for QSYMIA
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Capsules 3.75 mg/23 mg, 7.5 mg/46 mg, 11.25 mg/69 mg, 15 mg/92 mg ➤ Subscribe ➤ Sign Up

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
US Department of Justice
Chubb
Daiichi Sankyo
Farmers Insurance
Healthtrust
Colorcon
AstraZeneca
QuintilesIMS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.